Q3 2022 Neuropace Inc Earnings Call

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Good day and thank you for standing by welcome to the Q3 2022, Neuro Pes earnings Conference call.

At this time all participants are in listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you'll need to press star one one on your telephone you will then hear an automated message advising your hand is Reyes. Please be advised that today's conference is being recorded I would now.

To hand, the conference over to your Speaker today trip Taylor Investor Relations. Please go ahead.

Thank you operator, good afternoon, and thank you for participating in today's call joining me from neuro pace or Mike Raab, CEO and Rebecca Cohen CFO earlier today <unk> released its financial results for the third quarter ended September 32022.

Copy of the press release is available on the company's website.

Before we begin I'd like to remind you that management will make statements. During this call that include forward looking statements within the meaning of federal Securities laws, which are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of $19 95.

Any statements made during this call that relate to expectations or predictions of future events results or performance are forward looking statements. All forward looking statements, including those around narrow paces business development opportunities or projections market conditions clinical trials and those relating to our operating trends and future financial.

The impact of COVID-19 on our business and prospects for recovery expense management market opportunity revenue outlook and commercial expansion are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ.

From those implied by those forward looking statements. Accordingly, you should not place undue reliance on these statements for more detailed descriptions of the risks and uncertainties associated with our business. Please refer to the risk factors section of our public filings with the Securities and Exchange Commission or SEC, including <unk>.

Our annual report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 10, 2022, and our quarterly report on Form 10-Q to be filed with the SEC on November eight 2022, as well as any reports that we may file with the SEC in the future.

This conference call contains time sensitive information, which we believe is accurate only as of this live broadcast on November eight 2022, narrow case disclaims any intention or obligation except as required by law to update or revise any financial projections or forward looking statements, whether because of new information future events.

Or otherwise.

And with that I will now turn the call over to Mike.

Thanks, Chris.

Good afternoon, everyone and thank you for joining us I will start today's call with updates on our commercial progress in advancements with our clinical initiatives before turning the call over to Rebecca to provide details regarding our quarterly results and full year 2022 financial outlook.

We will then open the call to questions.

Our third quarter results represent increased adoption of rns therapy.

Total revenue was $11 2 million representing growth of 8% compared to the prior year period.

9% compared to the second quarter of 2022.

We drove strong initial implant revenue of $9 2 million representing growth of 18% compared to the prior year period and 15% sequentially.

Previously noted second quarter improvements in the upper <unk> monitoring unit or EMU operating environment contributed to an increased patient pipeline and strong rns system implants in the third quarter.

Along with improved market conditions awareness of the clinical benefits and differentiated features of rns therapy is growing and resonating with physicians.

Commercial and operational execution drove increased utilization of our technology within comprehensive epilepsy centers, which we believe demonstrates a higher percentage of overall IMU patients being treated with the RMS system.

In the third quarter, we observed stable IMU patient volumes sustaining the improvements we observed in the second quarter operating environment.

From our discussion with epilepsy centers, we anticipate continued gradual increases in the capacity for diagnostic monitoring of patients and thus an increase in the pipeline of potential interventional therapy candidates.

Dynamics normalize.

Now I would like to talk about three strategic growth objectives designed to drive increased utilization of rns therapy and comprehensive epilepsy centers.

By leveraging the expansion of our field team and distribution agreement with <unk> medical we are better positioned to one take share in the M use to increase the patient flow into end use through expanding referral networks and DTC marketing and three drive adoption of the rns system at additional comprehensive.

Obviously centers for CEC.

I'd like to further discuss our top focus of taking share in the IMU by treating an increased percentage of patients admitted for monitoring.

We believe consistent positive real world patient outcomes further proves the benefits of rns therapy to clinicians and as an imperative factor to support increased utilization of the technology.

Our team will continue to reiterate and emphasize the benefits of rns therapy for patients.

We are working to ensure clinicians include rns as an option in there and there are couple of FC treatment algorithms and educating them on expanded patient selection criteria for prescribing rns.

We are also prioritizing education of non prescribing clinicians that active Ccs in order to increase the overall number of prescribers.

Another important initiative is identifying potential rns patients earlier in the diagnostic process and providing patient education and awareness of the benefits of rns therapy.

Our recent agreement with <unk> medical to distribute their stereo EEG product portfolio.

<unk> improves the potential reach of these efforts by providing greater visibility earlier touch points with providers and patients in the diagnostic and therapy selection process.

We believe through earlier engagement, we can have greater influence in a stronger voice explaining the benefits of the RMS system.

We expect this will have a positive impact on the rns patient pipeline.

We are off to a strong start distributing the Dixie stereo EEG products and are pleased that the initial experience in the field and is aligned with the intended strategic rationale of the agreement.

As planned our team began selling <unk> products on October one.

Stereo EEG electrodes are used in comprehensive epilepsy centers to determine where epileptic seizures originate.

The stereo EEG approach to intracranial monitoring has become the predominant approach used in the United States with most rns patients and most surgical resection and ablation patients being localized with stereo EG prior to therapeutic intervention.

As a reminder, the intracranial monitoring market of the United States is estimated to be between $25 million to $40 million.

We believe the intracranial monitoring market is growing driven by the benefits of stereo EEG compared to the previous monitoring approaches and the adoption of newer intervention therapies, including rns.

Stereo EEG electrodes are sold to Cec's. The same call point, our team is focused on for the RMS and stuff.

Most rns implanting centers are not currently using Dixie electrodes, representing an opportunity for us to take share in this market <unk>.

Approximately two thirds of patients implanted with our RMS system are admitted to the MQ for intracranial monitoring.

Part of the process to identify where seizures originate.

Results from intracranial monitoring helps clinicians determine if the rns system that they fit for the patient.

As such we see this as a highly synergistic opportunity for our sales force to both generate additional revenue.

And strengthen our rns patient pipeline.

This opportunity.

On our prior efforts to provide earlier patient education on the benefits of rns therapy.

At the highest level commercially the entire team will remain focused on creating a more intervention mindset for treating drug resistant epilepsy patients in the <unk>.

In the third quarter, we were successful integrating and training the new members of our field team who joined in the first half of the year, we expect the ramping productivity aligned to high value opportunities, including access to patients earlier in the treatment continuum to be a growth driver.

I will now turn to provide an update on replacement implant revenue revs.

Revenue from replacement implants was $1 9 million in the third quarter of 2022.

Which was ahead of our expectations.

As we have discussed in the past we continue to expect quarterly replacement revenue to sequentially decline as the remaining first generation devices are replaced with the longer lasting second generation devices.

To provide continued transparency as of September 32022, there were 96 patients being actively treated with first generation devices.

We do not plan to provide this metric in 2023 as it becomes less and less material.

Given our historic approximately 90% replacement rate, we believe most of the remaining first generation devices will be replaced by the end of next year.

Moving to recent clinical updates and our Q2 earnings call, we announced the start of enrollment and the Nautilus study and we recently announced the first patient in the study was implanted with our RMS system following collection of baseline seizure information.

<unk> study is designed to evaluate the safety and efficacy of the rns system for the treatment of primary generalized epilepsy.

We intend for the results of this study to support a PMA supplement to expand the label for the RMS system.

Approximately 40% of drug resistant epilepsy patients have generalized epilepsy.

So our work on the Nautilus study as well as the work on the NIH funded one ex gas dose study represents a meaningful market expansion opportunity.

In addition to representing a large market opportunity generalized epilepsy is also a specific interest because surgical resection and ablation are not appropriate for these patients and there are no approved neuromodulation therapies.

Additionally, the process to diagnose and identifying patients is easier and faster than for focal epilepsy.

We're focused on bringing additional model of study sites online and we will continue to do so through the remainder of the year to support increased enrollment throughout 2023.

We are excited about the opportunity to offer the benefits of rns therapy to more people living with epilepsy.

In summary, we are pleased with the demonstrated increase in rns therapy utilization in the third quarter. We continue to increase the pipeline of patients considering rns and are converting patients to implants at higher rates or.

Our expanded sales force is ramping productivity in current accounts working to add new prescribers and creating patient referral networks.

Additionally, the team is beginning to leverage sales of <unk> medical stereo EEG electrodes to engage patients earlier in the therapy selection process to educate them on the benefits of rns therapy.

Lastly, we remain committed to expanding the market opportunity for our rns system into generalized epilepsy through execution of our Nautilus study.

While the <unk> operating environment remains constrained relative to past levels. We are encouraged by the stability over the past six months and encouraged by the positive commentary from clinicians regarding intentions to increase patient capacity.

Looking forward, we are well positioned to execute commercially and operationally to both expand and further penetrate the drug resistant epilepsy treatment market.

With that I will now turn the call over to Rebecca to detailed third quarter financial results.

Thanks, Mike.

Newer cases revenue for the third quarter of 2022 was $11 2 million.

Presenting growth of 8%.

<unk> Q $10 3 million.

For the third quarter of 2021, 9% sequentially compared to $10 $2 million.

Quite a 2022.

In the third quarter revenue from initial implants grew 18% to $9 2 million.

$7 8 million for the third quarter of 2021 sequentially initial implant revenue in the third quarter grew 15% compared to the second quarter.

Revenue from replacement implants was $1 9 million.

Compared to $2 5 million.

Third quarter 2021.

We continue to expect replacement implant revenue generally decrease for the next couple of years due to the transition to the current model of our device.

Been lasting battery.

Gross margin for the third quarter of 2020 was 71%.

Only 3% in the third quarter of 2021.

The decline in gross margin relative to the prior year was primarily due to a short term supply chain disruption, which was resolved in the third quarter.

Total operating expenses in the third quarter of 2020, Q were $18 2 million.

Compared with $13 8 million in the same period of the prior year.

As expected operating expenses in the third quarter, including costs associated with <unk> were flat to slightly down compared to the second quarter.

R&D expense in the third quarter of 2022 was $5 6 million.

<unk> was $4 3 million.

Same period of 2021.

The increase in R&D expense was primarily driven by an increase in personnel product development and clinical study expenses.

SG&A expense in the third quarter of 2020, Q was $12 6 million compared with $9 $4 million in it.

Higher year period.

The increase in SG&A was primarily driven by personnel related expenses.

And increased sales and marketing costs.

First of all expansion initiatives.

Loss from operations was $10 2 million in the third quarter of 2022 compared to $6 2 million.

In the prior year period.

We have a quite at $1 9 million and interest expense in the third quarter compared to $1 8 million in the prior year.

Net loss was $11 8 million for the third quarter of 2022 compared to $8 1 million in.

In the third quarter of 2021.

Our cash and short term investments balance as of.

<unk> was $85 4 million.

While our long term borrowings totaled $52 million.

Today, we are also announcing the filing of the shelf registration statement that includes an agreement that establishes the potential for aftermarket for <unk>.

Sales of the company's common stock.

We consider it to be prudent and consistent with good corporate practices to filed a registration statement at this time.

Provide flexibility for expeditiously raising capital in the future when we determine it would be best for the company.

Given our current position of cash and short term investment.

Absolutely $85 million as of September 32022, we do not have an immediate need to issue securities under the registration statement.

Now turning to our outlook for 2020.

We now expect total revenue between 44, five and $45 5 million.

Up from our previous guidance of <unk> 43.

With $45 million.

This is soon.

Initial implant revenue between 35 and $36 million in rips.

Placement revenue of nearly $8 million for the full year.

Lastly, we continue to expect to generate approximately $1 $5 million of revenue in the fourth quarter from a new partnership with <unk> medical.

Moving down the income statement, we continue to expect gross margin will be in the low 70% range.

This gross margin guidance includes revenue contribution from <unk> medical which has a lower gross margin than our core business.

We continue to expect 2022 total operating expenses will be in the range of $70 million to $75 million.

Of which approximately 1 million will be Dixie lines related expenses in the fourth quarter and approximately $89 million is noncash stock based compensation expense.

We expect operating expenses for the core <unk> business will be roughly flat sequentially in the fourth quarter given the steps we have taken to focus our business priorities and manage expenses in the second half of 2022.

This concludes our prepared remarks.

I would now like to turn the call back over to the operator, who will open the call for questions.

Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one on your telephone.

For your name to be announced.

Please standby, while we compile the Q&A roster.

Okay.

Our first question comes from the line of Robbie Marcus of Jpmorgan. Your line is now open.

Hi team. This is actually Allen on for Robbie Congrats on the quarter I just wanted to start off by asking about how trends have really gone so far through October and into November whether or not you.

You're really seeing that continued improvement in <unk> operating volumes, you saw through second quarter and third quarter and weather.

How we should frame that with the guidance that you've given.

Great. Thanks for the thanks for the question.

Hi, its stated earlier, we've seen really stable situation for the last six months through the third quarter and through the first month of the fourth quarter.

It's really encouraging for us because that provides the pipeline.

<unk> Ah patients perspective patients with you in our system.

And we've really seen that for the first time in a long time to be stable for a relatively extended period of time.

That's allowed us to execute against our commercial strategies the efforts to be able to increase utilization and drive increased patient awareness earlier in the process and continue to feel like that is setting us up for what we expect to be sequential growth in initial implants from Q2 to Q3, which we delivered and then from Q3.

As we head into Q4.

Got it.

And then when we think about how that should set for 2023. So you highlighted that it's been stable, but it sounds like it is still constrained to below past levels, what's really the timeline for getting back on the IMU and the pipeline back up to the levels that we saw pre COVID-19.

And how does that really sets you up to grow in 2023 relatives to current street expectations for give or take 20% growth next year understanding that you have informed the guidance yet.

What we're hearing from our customers from the from the comprehensive epilepsy centers.

The game used there is that their general expectation is that IMU volumes are going to continue to gradually increase over time.

That is driven by a number of factors, including <unk>.

Continuing to increase staffing in driving efficiencies within those centers.

That's the assumption that we're working off of and that's been the case here really for the last couple of quarters.

Dated borrowings.

Borrowing some other interruption, but just generally it's going to be a gradual increase in capacity as they as they worked through the new normal I think where we're past at this point I'd pass at this point talking about Covid impact, but we don't have to do that anymore. We're in a new normal for the last couple of quarters and expect based on what we're hearing that your volumes will be able to.

<unk> have stabilized and will be able to have <unk>.

Kris and capacity as the centers are allowed to bring more patient centered around how the capacity to bring more patients.

Okay. Thank you please standby Sir our next question.

Our next question comes from the line of Larry <unk> of Wells Fargo. Your line is now open.

Good afternoon, Thanks for taking the question and congrats on a nice quarter here Mike.

Quick one on and at an initial implant and then I wanted to ask about replacement.

Do you think there was any catch up here just wanted to make sure.

You beat by a significant amount here anything one time in.

In Q3.

We didn't really see anything that I would call. One time, we did see as you know.

An impact of Q and Q2 from the delay of procedures back the delay of IMU admissions back at the beginning of the year.

We saw that would be stable that number of patients to be stable through the second quarter into the third quarter. We had recovered what we believe were those catch up patients prior in the year and so really what we saw in Q3, we believe to be organic growth of the business.

Increased utilization and success of the commercial team executing against the strategy.

That's helpful.

Rebecca.

Mike I apologize for the math here, but im trying to understand how to think about replacement is going forward.

You gave us a 96 patients left on the prior generation, 90% of those get replace 86 left Q4 implied about 37, if I'm doing the math right.

On the guidance.

So <unk> got only like 50 or so left.

If I'm thinking about this right, which is a little less than $2 million. So how do we think about replacement revenue going forward.

And when do you when does the current generation.

Replacement start to.

When do you start to see that.

And when can replacements.

Sorry to grow so hopefully you understand I'm sure you understand kind of what I'm trying to get at thanks for taking the question.

Yes, thanks for the thanks for the question, Larry So I mean.

The guidance, we talked about nearly $9 million I'm, sorry, nearly $8 million of revenue. So just kind of taking that we're talking small numbers and granularity but nearer.

Nearly $8 million of revenue for the year in 2022, Tom Your math is generally right about the amount of replacement revenue. That's left following 2022, we're expecting most of that to be coming in 2023 is we're kind of well past the expected life of the prior generation devices as we head into 2010.

Three we.

We do expect that we'll start getting some of the early replacements of the next generation device. So as we move into subsequent years, we havent provided guidance as you know for revenue for 2023.

But we expect that we're reaching the end of the replacement cycle for the <unk> for the whole generation device by the end of next year and that there'll be small numbers keeping in my very small numbers of early replacements.

The next generation device that started kicking in.

Then we will be growing from that in subsequent years.

Thanks, so much.

As a reminder to ask a question. Please press star one on your telephone.

Our next question comes from the line of drew Ranieri of Morgan Stanley . Your line is now open.

Hi, This is Anna on for Tahira. Thank you so much for taking my questions maybe to start on that commercial organization, how should we be thinking about your sales force putting time between.

The initiatives you outlined expanding Anthony center is driving utilization.

<unk> is driving a problem network as well as selling.

Dixie products and then maybe to layer on to that is 52 reps. The right number there could there be another pressure in FY 'twenty three.

Great. Thank you for the question. So the focus of our field team is predominantly on increasing utilization with the comprehensive epilepsy centers. The team that we put together that included an expansion of the team in the first half of the year spending.

Spending most of their time on that increase in utilization, so thats focusing on centers that have been implanting the rns device.

More of the prescribers to prescribing expanding the way the physicians in those centers think about rns for their patients and then a push on the patient pipeline. So awareness of the patients that are working their way through the diagnostic process out those centers. So that we can influence more of those patients to move on to rns therapy Dixie players.

Right into that so that the customers we're selling the Dixie products are the same ones that were selling the rns device to the patients that are going through the diagnostic process using the Dixie electrodes are potential candidates for the <unk> device.

So leveraging that with the same team selling to the same customers both the increased utilization as well as.

Selling the <unk> product and looking at opportunities to be able to convert.

Furtive accounts over to using the over to using the <unk> product.

We've also have with the field team effort that they're putting into referral development.

Expanding patient centers, but just again emphasizing that the majority of the focus of the field team is on increasing utilization within the within the comprehensive epilepsy centers and Dixie fits right in with that so it's very much hand in hand, with the with the core <unk> business and how do we approach that new product and we haven't provided guidance.

<unk> for 2023, but we did communicated previously that the expansion that we did $2 52 people on the sales organization in the first half of the year that our focus for the second half of the year was getting those people trained and productive in the field and so that hasnt changed were expecting to be staying at a stable sales force through.

The end of the year and then we will be evaluating what opportunities are beyond that but expect that we'll be continuing to grow revenue at a faster pace than we're growing spending. So we're at a point in our evolution, where we believe that there is commercial leverage and so we're not looking to we're not looking to spend out ahead of.

But being able to use that.

The growth of the business to be able to to support <unk>.

Moving towards profitability, and then spending within the organization consistent with that.

Thank you and then and then maybe just I wanted to make sure I understood. Your response to Larry's question correctly should we be thinking about that.

The backlog of patients.

Deferred treatment as completely worked through our.

Could there be potential upside from the backlog to <unk> or to Tony Tony sorry.

Thanks for taking my questions.

The backlog of patients. So as we think about the backlog of patients. It's primarily patients that are working their way through the epilepsy monitoring unit.

The feedback we get from our customers is that in both cases, they still have waiting list of patients who are going to come through and as they are able to increase their capacity.

That's part of the commentary I gave about generally expecting.

Gradual increase in the number of patients who are working through the abuse.

So I don't think about it as backlog specifically for patients that have been worked up and identified for rns implant. It's more globally a backlog of patients that are working their way through the diagnostic process at the epilepsy centers.

And then again, Matt growing gradually over time as the centers are able to increase capacity.

At this time I'm showing no further questions I'd now like to turn it back to Mike for closing remark.

Thank you all for joining us today have a great evening.

You for your participation in today's conference. This does conclude the program you may now disconnect.

Okay.

The conference will begin shortly to raise Johan during Q&A you can dial one one.

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Q3 2022 Neuropace Inc Earnings Call

Demo

Neuropace

Earnings

Q3 2022 Neuropace Inc Earnings Call

NPCE

Tuesday, November 8th, 2022 at 9:30 PM

Transcript

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